Interesting Discussion Potential Issues for Auditing ISO 9001:2015

Sidney Vianna

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Big Jim

Admin
Yukon didn't read the standard very well. In the appendix you will find that retained documented information is the new term for what was know before as records and maintained documented information is the new term for what was known before as documents.

I have made a list of the elements of the standard that deals with each of these categories. PM me if you would like a copy.
 

AndyN

Moved On
It's amazing to me that basic stuff in ISO 9001 isn't understood even after 3+ years, particularly by CB auditors. Recently, I had experienced a situation where a CB auditor had reported a non-conformity because the quality manual wasn't "numbered" and didn't have a revision on it. I'm unsurprised that (some) auditors can't tell one requirement from another - however, clearly, CB Management would do well to critically review what their auditor competencies actually are.
 
Y

Yukon

Documented information is the new 2015 term for records. You need no documents ( test instructions, work instructions, schematics, quality manuals, etc) only documented information (record). This is perhaps the single biggest mistake that was incorporated into the 2015 version. It will prove disastrous.
 

Sidney Vianna

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Documented information is the new 2015 term for records. You need no documents ( test instructions, work instructions, schematics, quality manuals, etc) only documented information (record). This is perhaps the single biggest mistake that was incorporated into the 2015 version. It will prove disastrous.
You are undoubtedly wrong if you think that documented information equates only to records. Why don't you pay attention to the ISO document I hyperlinked a couple of posts ago? In the document it clearly states:

What is documented information? - Definitions and references

The term Documented information was introduced as part of the common High Level Structure (HLS) and common terms for Management System Standards (MSS).

The definition of documented information can be found in ISO 9000 Clause 3.8.

Documented information can be used to communicate a message, provide evidence of what was planned has actually been done, or knowledge sharing.

The following are some of the main objectives of an organization’s documented information independent of whether or not it has implemented a formal QMS;

a) Communication of Information

As a tool for information transmission and communication. The type and extent of the documented information will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.​

b) Evidence of conformity
Provision of evidence that what was planned has actually been done.​

c) Knowledge sharing

d) To disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product or service.

The concept of documented information is addressed in ISO 9001:2015 Annex A6. Commonly used Terms and definitions relating to documented information are presented in ISO 9000:2015 Clause 3.8.

It must be stressed that, according to ISO 9000:2015 Clause 3.8.6 Note 1, documented information can be in any format and media and from any source and the definition of “document” in ISO 9000:2015 Clause 3.8.5 gives the following examples of media:

  • paper
  • magnetic
  • electronic or optical computer disc
  • photograph
  • master sample
And the ISO 9000 definition of documented information:

Potential Issues for Auditing ISO 9001:2015
 

Big Jim

Admin
Also see what ISO 9001:2015 itself says about documented information in Annex A.6. Read the whole thing, but here are some highlights. Where ISO 9001:2008 used specific terminology such as "document" . . . this edition (2015) defines as "maintain documented information". Where ISO 9001:2008 used the term records . . . is now expressed as a requirement to "retain documented information" . . .
 

Jen Kirley

Quality and Auditing Expert
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It's amazing to me that basic stuff in ISO 9001 isn't understood even after 3+ years, particularly by CB auditors. Recently, I had experienced a situation where a CB auditor had reported a non-conformity because the quality manual wasn't "numbered" and didn't have a revision on it. I'm unsurprised that (some) auditors can't tell one requirement from another - however, clearly, CB Management would do well to critically review what their auditor competencies actually are.
Since I was not there and that auditor is not here to defend himself, I have to ask how he wrote that NC and how the client manages version control if the manual does not identify its version.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
It hasn't been revised! A look at the document control note would have confirmed that. But he jumped to an assumption...
Where is the document control note?

How is the user to know he/she is looking at the correct (original, in this case) version?
 
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